University of Manitoba
Winnipeg, Manitoba, R3E 3P5, Canada
NCT Number: NCT03392727
This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.
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All sexes
Interventional
Not applicable
Winnipeg, Manitoba, R3E 3P5, Canada
The proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in Winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. An additional comparison group will be parents who already have a baby box at the time of recruitment. This group will also receive the safe sleep pamphlet. Families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. Administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes.
Families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference.
PHIN will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. Postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Baby box (bassinet) with infant items
Baby box (bassinet)
Face to face education and baby box orientation session
Online baby box education
Time frame: 2 months
Parents with a baby box
Time frame: 2 months
crib, cradle, bassinet, box, other
Time frame: 2 months
always/sometimes/never/not applicable
Time frame: 2 months
supine, other
Time frame: 2 months
sleeper, sack, swaddled
Time frame: 2 months
none, tucked blanket, other
Time frame: 2 months
safe sleep location, position, infant clothing, bedding (1 point each)
Time frame: 2 months
breastfeeding, formula feeding, both
Time frame: 2 months
total number of cigarettes smoked per day in the household
Time frame: 2 months
Infant provided daily dose of Vitamin D (always/sometimes/never)
Time frame: 12 months
Number of infant immunizations in the first year of life
Time frame: 9 months
Number of prenatal visits
Time frame: 12 months
Infant hospitalizations in the first year of life (number of hospitalizations, total hospital days, respiratory vs. non-respiratory hospital days)
Time frame: 2 months
Parent-reported adverse events and concerns regarding the baby box
Time frame: 2 months
Parent-reported opinions and preferences (likes/dislikes) regarding the baby box and the distribution process
University of Manitoba
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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